WALTHAM, MA--(Marketwire - March 25, 2010) -
EyeGate Pharma, a privately held venture-backed pharmaceutical company developing a non-invasive ocular drug delivery platform and ocular therapeutics, announces today the completion of a Phase II study of its lead product candidate, EGP-437, for the treatment of anterior uveitis.
In order to be enrolled in this randomized double-masked study, subjects needed to have non-infectious anterior segment uveitis with a cell score of > 1.5 (on a 0 - 5 scale, 5 = worst and 0 = best). Enrolled subjects received a single dose of EGP-437 (a dexamethasone derived corticosteroid solution) delivered at one of four dose levels using the EyeGate® II Ocular Drug Delivery System, and were followed for 28 days. Following the single EGP-437 treatment, about half of the subjects achieved an anterior cell score of zero within two weeks. By day 28, the majority of patients achieved cell scores of zero and required no further treatment. No significant changes in intraocular pressure or signs of cataract formation were detected. Data from the study will be presented at the Association for Research in Vision and Ophthalmology annual meeting in Fort Lauderdale on May 06, 2010.
One of the study investigators, Victor L. Perez, M.D., Associate Professor of Ophthalmology at the Bascom Palmer Eye Institute, said: "For uveitis patients, there is an unmet medical need, and doctors need a more predictable, effective treatment for severe uveitis. The EGP-437 Phase II data is encouraging because it not only shows promising signs of efficacy but addresses compliance issues, by providing the doctor direct control of the dosing. These results suggest that the EyeGate delivery system could lead to a more predictable clinical response in treating severe uveitis."
EyeGate is the first company to complete Phase II studies using iontophoresis technology to deliver an active compound into the eye under an investigational new drug (IND) application. The Company submitted the anterior uveitis study results and data from a completed Phase II study in dry eye patients to the FDA as part of an end-of-Phase II meeting. In the second quarter of 2010, the Company plans to initiate a multi-center Phase III study in dry eye patients.
Stephen From, President and Chief Executive Officer of EyeGate Pharma, commented, "We are pleased that EyeGate has successfully completed two Phase II studies, one for dry eye and one for anterior uveitis, using our iontophoresis technology to deliver EGP-437. These positive results help demonstrate that iontophoretically delivered drugs may offer Ophthalmologists new treatment options for patients."
Uveitis is an inflammatory condition of the internal structures of the eye that can lead to cataract, glaucoma, scarring, pain, photophobia, and even permanent loss of vision when undiagnosed or treated poorly. Uveitis is a leading cause of blindness and is estimated to occur in 102 of every 100,000 adults in the U.S. per year.
About EyeGate Pharma
Eyegate Pharmaceuticals, Inc. is focused on developing treatments for unmet ocular medical needs by employing the EyeGate® II Ocular Drug Delivery System, a non-invasive drug delivery technology. The EyeGate® II delivery system is compatible with a wide range of therapeutics and has the potential to address many anterior and posterior segment diseases. EyeGate® II has been studied in over 200 subjects and is the first ocular iontophoretic system to have completed Phase II studies (Dry Eye and Uveitis). For more information, please visit www.eyegatepharma.com.